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510(k) K955170

NEXFLEX FEMORAL STEM, STANDARD DESIGN by Nexmed, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1996
Date Received
November 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by Nexmed, Inc.

  • K033580 — NEXFLEX TOTAL HIP SYSTEM (August 5, 2004)
  • K991882 — NEXFLEX TOTAL KNEE SYSTEM (December 8, 1999)
  • K955171 — NEXLOCK FEMORAL STEM (February 9, 1996)
  • K952629 — NEXFLEX TOTAL HIP SYSTEM (September 8, 1995)
  • K951656 — NEXMED CANCELLOUS BONE SCREWS (July 18, 1995)

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